Method for protecting and using biopsy system instruments while maintaining a sterile or aseptic state

ABSTRACT

A method for reducing the risk of contamination of a sterile biopsy system, via a sterile sheath with an exterior structure to aid in opening the sheath, and further having a self-sealing target disposed at an opposing closed end of said sheath.

FIELD OF THE INVENTION

The present invention generally relates to medical equipment, and more particularly relates to medical equipment which must be covered with a sheath during medical procedures, and more particularly relates to methods and systems for permitting easy deployment of a sterile sheath over a biopsy system and for permitting insertion of a needle through said sheath while maintaining the sterile or aseptic state of the object inside the sheath.

BACKGROUND OF THE INVENTION

In recent years, medical professionals have used various types of biopsy systems to collect tissue from internal regions of the body. These biopsy systems are typically either enclosed in a sterile disposable sheath prior to use on any patient, or they are cleaned periodically. The biopsy system may be a mechanical or electro-mechanical device. One example of a biopsy system is the Vacora brand of biopsy system made by CR Bard Company. This is a vacuum-assisted breast biopsy system which is completely handheld. The biopsy needle is a sterile one-use item. Often, it is difficult to insert the biopsy system and the biopsy needle into a sheath. One example of a prior art sheath is disclosed in U.S. Pat. No. 5,910,113 to Rick L. Pruter, which shows a sheath with a support structure disposed inside the sheath at the open end (the opposite end is closed). Another example of a prior art sheath is disclosed in U.S. Pat. No. 5,061,246 to Emmanuel Anapliotis, which also has support structure at the open insertion end (this sheath also has an open opposing end).

While such sheaths have been used extensively in the past, the production of these sheaths is time consuming and, therefore, costly. They also provide limited protection in the case of the open-end design of Anapliotis and are susceptible to tears, with the Pruter design, if a needle or other instrument penetrates through the sheath.

Consequently, there exists a need for improved methods and systems for protecting biopsy systems in an efficient manner, while simultaneously maintaining the sterile or aseptic state of the system after a needle or other instrument pierces the sheath and travels from inside the sheath to outside the sheath.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a system and method for covering biopsy system equipment in an efficient manner.

It is a feature of the present invention to utilize a sterile sheath with an external structural support at the open end to aid in insertion of the biopsy system and other matter which may be disposed inside the sheath.

It is another feature of the present invention to include a sterile target coupled to the sterile sheath.

It is an advantage of the present invention to achieve improved efficiency in manufacturing sterile sheaths with an entry opening support structure.

It is an advantage of the present invention to provide reduced ability for tearing of a sterile sheath when a needle passes through the closed end.

It is another advantage of the present invention to reduce the opportunity for contamination of the biopsy system through the hole made by the needle.

The present invention is an apparatus and method for covering biopsy systems designed to satisfy the aforementioned needs, provide the previously stated objects, include the above-listed features, and achieve the already articulated advantages. The present invention is carried out in a “wasted time-less”manner in a sense that the time consumed, during manufacturing, with sealing an opening support structure within the sheath, has been eliminated. The invention is also accomplished in a “tear-less” or “contamination-less” manner in the sense that the contamination that may be exposed to the internal biopsy system through a tear in the sheath after a needle is caused to exit the inside of the sheath, has been reduced.

Accordingly, the present invention is a system and method including a sterile sheath disposed over a biopsy system with an external sheath entry end aiding structure, as well as a self-sealing target disposed at an opposite end.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more fully understood by reading the following description of the preferred embodiments of the invention, in conjunction with the appended drawings wherein:

FIG. 1 is a side view of the sheath system of the present invention, in a collapsed configuration before insertion of a biopsy system.

FIG. 2 is a perspective view of the external support structure sheath of FIG. 1 in conjunction with a representative biopsy system and needle during the process of insertion of the biopsy system into the sheath.

FIG. 3 is a side view of a sheath of FIG. 2 after the biopsy system has been inserted further into the sheath; the dotted lines reveal the view of the biopsy system and needle which are inside the sheath.

FIG. 4 is a side view of the sheath of FIG. 3 after the biopsy system and needle have been fully inserted; the dotted lines reveal the view of the biopsy system and needle which are inside the sheath.

FIG. 5 is a side view of the sheath of FIG. 4 after the removable external structure and handle have been detached.

FIG. 6 is a side view of the sheath of FIG. 5 after the flap has been closed.

FIG. 7 is a perspective view of the sheath of FIG. 4 where the sheath is shown as transparent and the target is shown pierced at a central point by the needle.

FIG. 8 is a perspective view of the needle or cannula-receiving target which shows that it has a needle or cannula exiting hole therein, as well as an exterior backflow retarding seal.

FIG. 9 is a cross-sectional view of the view of FIG. 8 which shows the sheath clinging to the needle and acting as a backflow retarding seal.

DETAILED DESCRIPTION

Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to FIG. 1, there is shown a biopsy system sheath system of the present invention generally designated 100, including a sheath body portion 130 having a biopsy system insertion end 102 and an opposing needle or cannula exiting end 104. Preferably, sheath body portion 130 is made of plastic film, similar to materials used in the prior art for sterile drapes and transceiver covers. In one embodiment, exterior sheath support structure top end 112 is made of a semi-rigid tape, having an adhesive on one side and a non-adhesive opposing side. Exterior sheath support structure top end 112 could also be a cardboard-like material with adhesive or a plastic-type material which can be “welded”, using known techniques, to the sheath body portion 130. Exterior sheath support structure top end 112 can be disposed outside of the sheath body portion 130 by folding over an end section of the sheath body portion 130 so as to cover the exterior sheath support structure top end 112. A weld or other closure technique can be used to seal the exterior sheath support structure top end 112 within the new pouch created on the outside of the sheath body portion 130. Preferably, handle 110 and exterior sheath support structure top end 112 are detachably coupled to the sheath body portion 130 via a handle detaching perforation 114. Other means of easily removing the handle could be used as well. It should be understood that the present invention can be constructed with or without a handle 110. The sheath can be constructed so that the entire handle portion is removable after insertion of the biopsy system. This will permit the sheath to be closed by use of double-sided tape, ziplock baggy-type seals or other ways to seal the open end. In this configuration, a perforation of the sheath between the exterior sheath support structure top end 112 and the sealing tape or baggy seal would facilitate complete detachment of the handle before the sheath is sealed up prior to use.

Preferably, the sheath body portion 130 is serially folded or folded like an accordion or otherwise configured to be automatically or telescopically deployed from a collapsed position to an expanded position with relative ease. Needle or cannula-receiving target 120 is preferably disposed at the needle or cannula-exiting end 104 at a central location; however, other orientations and locations of needle or cannula-receiving target 120 could be located elsewhere. In a preferred embodiment of the present invention, needle or cannula-receiving target 120 comprises a circular target having a semi-rigid characteristic and having a needle or cannula-exiting hole 122, which exposes a portion of the sheath. The relatively small hole surrounded by the target helps to limit tearing of the sheath after it is pierced by the needle. Needle or cannula-receiving target 120 may be made of tape or other material which is adhered to the exterior of sheath body portion 130. However, needle or cannula-receiving target 120 may be welded to sheath body portion 130. It may be disposed inside the sheath body portion 130 as well. This novel idea is capable of providing many benefits irrespective of minor deviations from the described preferred embodiment and preferred use. Needle or cannula-receiving target 120 may be colored or otherwise configured to provide for easy registration of the needle 202 with the needle or cannula-exiting hole 122. Needle or cannula-receiving target 120 may be made from the same material as exterior sheath support structure top end 112, and it may share the same or similar attachment means to the sheath body portion 130. Needle or cannula-receiving target 120 helps to prevent tearing of the sheath by adhering to the sheath in an area around the hole created by the needle which area helps to absorb or spread out the forces on the sheath, which otherwise may result in tearing of the sheath beyond the piercing of the sheath by the needle or cannula. When the term “target” is used herein, it is intended to refer to any visible structure disposed interior or exterior to the sheath which is configured to aid in locating a point to pierce with the needle and simultaneously inhibit tearing of said sheath beyond the target when a needle or cannula pierces said sheath at said target. Needle or cannula-receiving target 120 may be as simple as a disk or other shaped adhesive patch-like object adhered to the sheath. In a more sophisticated design, needle or cannula-receiving target 120 could be an “O” ring or other flexible material, such as memory foam, or other material capable of receiving therethrough a needle or cannula and capable of returning to its original shape or near original shape upon removal of said needle or cannula.

A more detailed understanding of the present invention can be achieved by now referring to FIG. 2, which shows an enlarged perspective view of the sheath system 100 of FIG. 1. FIG. 2 further shows a biopsy system 200, which may be an ultrasound transducer or a gamma ray receiver or similar substitute. Exterior sheath support structure top end 112 is shown in a fully deployed orientation where it has been opened to form a hole or tunnel through which the needle 202 can be inserted. Exterior sheath support structure top end 112 is shown as being generally rectangular in shape so as to form a top-less and bottom-less rectangular box, through which the needle 202 and the biopsy system 200 are inserted. However, it should be understood that other non-rectangular shapes could be used as well.

An even more detailed understanding of the present invention may be achieved by now referring to FIG. 3, which shows the sterile sheath 100 with the needle 202 and biopsy system 200 partially disposed therein. The dashed lines show the biopsy system 200 and the needle 202 which would otherwise be concealed by the exterior sheath support structure top end 112, sheath body portion 130 and needle or cannula-receiving target 120. A portion of the handle 110 is shown in dashed lines as it is occluded from view by the biopsy system 200. Needle tip 302 is shown exiting from the needle or cannula-receiving target 120 through needle or cannula-exiting hole 122.

Now referring to FIG. 4, there is shown a system of the present invention after the biopsy system 200 has been fully inserted. The dotted lines show the biopsy system 200 hidden behind the sheath body portion 130.

Now referring to FIG. 5, there is shown a system of the present invention after exterior sheath support structure top end 112 has been separated along handle detaching perforation 114. Again, it should be understood that it may be desirable to completely remove the entire handle and not utilize the perforation of the handle.

Now referring to FIG. 6, there is shown a system of FIG. 5 after the biopsy system insertion end 102 has been closed up.

Now referring to FIG. 7, there is a perspective view of the system of the present invention.

Now referring to FIG. 8, there is shown a close-up perspective view of the needle or cannula-receiving target 120 with the needle or cannula-exiting hole 122. It is also shown to have a backflow retarding seal 800, which is designed to cling to the needle as it passes therethrough. The materials for backflow retarding seal 800 may be plastic film or any suitable material which would tend to resist tearing while tending to cling to or be biased toward the needle. This clinging to or pressure on the needle helps to retard backward contamination of the biopsy system 200 through the needle or cannula-receiving target 120. It should be understood that the present invention can be utilized with or without the backflow retarding seal 800.

In operation, the apparatus and method of the present invention as described in FIGS. 1-7, could function as follows: a biopsy system 200 with a needle 202 attached thereto is inserted, by a physician, into an opened biopsy system insertion end 102. The needle tip 302 of needle 202 pierces through the needle or cannula-exiting hole 122 of the needle or cannula-receiving target 120; the biopsy system 200 is further inserted until completely in the sheath body portion 130. The exterior sheath support structure top end 112 is then detached along handle detaching perforation 114, so that the sheath body portion 130 is not a hindrance during use of the biopsy system 200.

Throughout this description, reference is made to sterile or a sterile sheath or other sterile items. It should be understood that this could refer to any state of cleanliness with respect to living organisms or a media upon which living organisms could grow. The present invention is intended to cover items that are aseptic, as well as sterile.

Throughout this description, reference is made to a physician. The present invention is intended to apply to any person, such as, but not limited to, physicians, physicians' assistants, nurses, medical imaging specialists, veterinarians, veterinarians' assistants, industrial clean room technicians, etc.

Throughout this description, reference is made to a biopsy system or other medical equipment. The present invention is intended to apply to any environment, such as, but not limited to, medical, veterinary or clean room applications, etc.

The term “outside the sheath” is used herein to mean being on a side of said sheath which is opposite a side of the sheath which is generally the inside of said sheath. This “outside of the sheath” is also meant to include within a pouch formed on the outside of the sheath by folding the outside of the sheath over onto itself.

The present invention is described in a preferred embodiment as having both an external-to-the-sheath support structure and a needle-receiving target. It should be understood that the target of the present invention can be used with an internal support structure, or it can be used with a sheath without any support structure. The external-to-the-sheath support structure of the present invention could likewise be used without either an internal or external needle target.

It is thought that the method and apparatus of the present invention will be understood from the foregoing description and that it will be apparent that various changes may be made in the form, construct steps, and arrangement of the parts and steps thereof, without departing from the spirit and scope of the invention or sacrificing all of their material advantages. The form herein described is merely a preferred exemplary embodiment thereof. 

1. A method of limiting contamination by covering a biopsy system comprising the steps of: providing an expandable sheath having a first open end and an opposing closed end and being made of a plastic film; said expandable sheath sized and configured for receiving a biopsy system; providing an external to said expandable sheath support structure for holding open said first open end to aid in insertion of said biopsy system; providing a needle penetration target affixed at said opposing closed end, said needle penetration target configured to inhibit an elongation of needle penetration caused tearing of said sheath; holding open said first open end; inserting into said first open end said biopsy system; and penetrating said needle penetration target from inside said expandable sheath by a sharp portion of said biopsy system.
 2. The method of claim 1 wherein said external to said expandable sheath support structure and expandable sheath are coupled via an adhesive comprising an adhesive tape affixed to an exterior of said expandable sheath.
 3. The method of claim 2 wherein said needle penetration target is affixed to an outside surface of said expandable sheath and comprises a circular target with a needle or cannula-exiting hole.
 4. The method of claim 3 wherein said expandable sheath comprises a serially folded sheath.
 5. The method of claim 4 wherein said serially folded sheath is self telescoping upon increasing insertion of a biopsy system.
 6. The method of claim 5 wherein said needle or cannula-exiting hole is further covered by a backflow retarding seal.
 7. A method for covering a biopsy system to reduce contamination, the method comprising the steps of: providing a self-expanding sterilizable sheath having a first open end and an opposing closed end; said self-expanding sterilizable sheath being sized and configured for receiving a biopsy system and comprising a support structure disposed at said first open end for aiding in insertion of a biopsy system; providing a needle penetrating target disposed at said opposing closed end; providing structure disposed outside said sheath and at an open end of said self expanding sterilizable sheath, said structure being configured for holding open said open end; inserting said biopsy system into said self expanding sterilizable sheath so said self-expanding sterilizable sheath expands automatically to accommodate further insertion of said biopsy system; piercing said needle penetrating target with a sharp portion of said biopsy system, and thereby causing a void in said needle penetrating target to exist; and moving said sharp portion of said biopsy system from within said self-expanding sterilizable sheath to a position exterior of said self-expanding sterilizable sheath.
 8. A method of limiting contamination of a biopsy system comprising the steps of: providing a sheath having an open end and an opposing closed end; providing a target structure at said opposing closed end, wherein said target structure is sized and configured to receive a needle; said target having a sealing structure for limiting an extent of tearing and contamination through tears in said sheath when a needle is passed therethrough; passing an instrument from inside said sheath to outside said sheath by piercing a central area of said sealing structure; wherein said instrument is a needle and said handle comprises a detachable handle end at said open end and further comprising the steps of: detaching said detachable handle end before performing a biopsy with said needle; and further comprising the steps of sealing said sheath after detaching said detachable handle end.
 9. A method for reducing contamination of a biopsy system comprising: providing a means for covering a biopsy system; providing means, exterior to said means for covering, for holding open said means for covering to aid insertion of said biopsy system; providing means for limiting tearing resulting from a puncture at a predetermined location, where the puncture is caused by piercing said means for covering at said predetermination location with a sharp portion of said biopsy system disposed within said means for covering.
 10. The method of claim 9 wherein said means for covering comprising a sheath.
 11. The method of claim 10 wherein said means, exterior to said means for covering, for holding open said means for covering comprises a flexible member comprising a contact adhesive side for coupling with said sheath.
 12. The method of claim 11 wherein said means for limiting tearing comprises an adhesive-backed patch adhering to said sheath.
 13. The method of claim 12 wherein said sheath comprises a perforation configured to permit rapid detachment of said flexible member from a remaining portion of said sheath; and further comprising the steps of: grasping said flexible member and tearing said sheath along said perforation so as to detach said flexible member from said remaining portion of said sheath. 